WELMEC 6.1 (Issue 1) WELMEC European cooperation in legal metrology Application of Directives 75/106/EEC and 76/211/EEC concerning the marking and quantity control of e-marked prepackages Definitions of terms September 1997 2
WELMEC European cooperation in legal metrology FRONTISPIECE WELMEC is a cooperation between the legal metrology authorities of the Member States of the European Union and EFTA. This document is one of a number of guides published by WELMEC. These guides are purely advisor and do not themselves impose any restrictions or additional technical requirements beyond those contained in relevant EC directives. Alternative approaches may be acceptable, but the guidance provided in this document represents the considered view of WELMEC as to the best practice to be followed. Published by: WELMEC Secretariat NWML Stanton Avenue Teddington United Kingdom Tel: +44 181 943 7216 Fax: +44 181 943 7270 Email: welmec@nwml.gov.uk 3
Table of contents Table of contents 1 Introduction to the document 2 General 2 Disclaimer 2 Definitions of terms 2 terms 1-15 3 terms 16-33 4 terms 34-48 5 terms 49-56 6 terms 57-67 7 terms 68-79 8 terms 80-89 9 terms 90-107 10 terms 108-122 11 1
Introduction to the document General Member states of the European Economic Area have implemented the Council Directives 75/106/EEC of 19 December 1974 and 76/211/EEC of 20 January 1976 in their national legislation. The directives deal with marking and quantity control of e-marked prepackages. This document is part of a series of documents (to be) published by WELMEC: 6.0 Introduction to prepackaging 6.1 Definitions of terms 6.2 Translations of terms 6.3 Implementation of the directives 6.4 Guide for packers 6.5 Guide for inspectors 6.6 Guide for system evaluators This series of documents intends to provide guidance to all those concerned with the application of directives 75/106 and 76/211/EEC on e-marked prepackages. They will lead to a uniform interpretation and enforcement of these directives and assist in the removal of barriers to trade. Disclaimer Please note that this series of documents does not deal with matters not covered by the above directives, such as requirements for certain products to be made up in prescribed quantities, and controls on non e-marked packages. Definitions of terms This document provides for definitions of terms used in the area of prepackaging. It consists of a table with four columns. In the first column the number of the term is listed. In the second column the term itself is listed. In the third column the definition of the term is given. In the fourth column references are given (if applicable): - references to where in the directives the term is used are printed in normal text, - references to other terms in this list are printed in italic, - references printed in bold refer to places where the definition is given. 2
1 Acceptable batch A batch of prepackages shall be considered acceptable if the results of the check covering the actual contents of each prepackage in the sample and the check on the average of the actual contents of the prepackages in the sample satisfy the acceptance criteria. 2 Actual capacity The volume of liquid a bottle used as a measuring container in fact contains when it is filled exactly under the conditions corresponding theoretically to the nominal capacity at a temperature of 20 C. 75/106 and 76/211/EEC, Annex II, 2 75/107/EEC, Annex I, 1.3 Filling volume 3 Actual contents The quantity of product which the prepackage in fact contains. 76/211/EEC, Annex I, 2.2 4 Actual volume The volume of liquid a prepackage in fact contains at a temperature of 20 C. 75/106/EEC, Annex I, 2.2 5 Aerosol dispenser Any non-reusable container made of metal, glass or plastic and containing a gas 75/324/EEC compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state. 6 Average system A system with fill quantity specifications according to which the mean value of a 75/106 and 76/211/EEC, Annex I, 1 manufactured quantity may not be less than the nominal fill quantity. For e-marking there are also restrictions on the number of individual prepackages substantially below the nominal quantity. 7 Batch All the prepackages of the same nominal quantity, the same type and the same production run, packed in the same place, which are to be inspected. 75/106 and 76/211/EEC, Annex II, 2.1.1 Group, Inspection lot ISO 3545 4.5 8 Brim capacity The volume of liquid a bottle contains when filled to the brim. 75/107/EEC, Annex I, 1.2 9 Brimful volume The volume a measuring container bottle contains if it is filled to the upper brim level. 10 Canned foods Foodstuffs in a can, heat treated to remove micro-organisms in order to preserve the contents for safe use for at least 18 months. 11 Catchweight products Packages not made up in a predetermined constant quantity. 12 Check by competent department Statistical sampling check with effectiveness comparable to that of the reference method specified in Annex II of the Directive. 13 Check by packer Production check performed by a packer in a Member State in accordance with procedures recognised by a competent department. 14 Combination package A single prepackage containing a number of packages with products of different kinds which are not intended to be sold separately. 15 Competent department Department appointed by a Member State for specific tasks. Reference test 75/106 and 76/211/EEC, Annex I, 5 Production checks 75/106 and 76/211/EEC, Annex I, 4 (clause 5) Mixed packages 3
16 Constant quantity A particular quantity, being the same quantity for all packages in a group of packages. Prepacked products in predetermined quantities 17 Consumer Each natural or legal person who acquires or buys products to use them. (In some countries this applies only to natural persons.) 18 Consumer package A package that is customarily produced or distributed for sale to final purchasers through retail sales agencies or other means. 19 Container A vessel, box, etc. for holding particular things. 4 Ultimate consumer Person OIML R79 (1996), 2.6 20 Criterion for acceptance Criterion for a batch to be considered acceptable with regards to the number of 75/106 and 76/211/EEC, Annex II, 2 defective prepackages and the average actual contents of the individual prepackages. 21 Criterion for rejection Criterion for a batch to be rejected with regards to the number of defective 75/106 and 76/211/EEC, Annex II, 2 prepackages and/or the average actual contents of the individual prepackages. 22 Defective prepackage Prepackage in the batch whose actual contents are less than the minimum acceptable contents. 75/106 and 76/211/EEC, Annex II, 2.2 Non-standard package 23 Density The relation of the weight of a product to its volume. Weight 24 Desiccating goods Any goods which, notwithstanding that they are made up in packages, lose weight or volume solely through evaporation after they are made up, and desiccate. 25 Destructive testing Testing which involves opening or destroying the package. 75/106 and 76/211/EEC, Annex II, 2 26 Direct sale The sale of prepackages to the ultimate consumer by the packer. 27 Drained weight In respect of solid foods presented in a liquid medium this means the weight of solid Filled weight parts determined in accordance with a procedure laid down in 79/112/EEC, Article 17. 28 Duty to inform The duty of a packer or an importer to inform a competent department on specified matters. Recording duty 75/106 and 76/211/EEC, Annex I, 4 (clause 5) 29 EEC 3 mark A reversed epsilon for marking measuring container bottles. 75/107/EEC; 75/324/EEC 30 EEC e mark The small letter e having the form shown in the drawing in section 3 of annex II to Directive 71/316/EEC. 31 Empty space (vacuity) The empty space of a measuring container bottle is the difference between brimful volume and nominal volume. 32 Error of measurement The criteria for the measurement of uncertainty of contents when carrying out a reference test. 33 Fancy packing Packing containing foodstuffs and brought onto the market for particular occasions, as well as the packing obviously bought by the consumer because of the nature of the packing and not so much because of the nature of the foodstuff. 75/106 and 76/211/EEC, Annex I, 3.3 Uncertainty of measurement 75/106 and 76/211/EEC, Annex II, 1 (clause 2)
34 Filled weight In respect of solid foods presented in a liquid medium this means the weighed-in amount of solid foods at the time of packing. 35 Filling method The method that the packing line applies to producing the prepacked goods. 36 Filling volume The fluid volume a measuring container bottle will really contain at a temperature of 20 C if all theoretical conditions for reaching the nominal volume are fulfilled. 37 Frozen With regard to poultrymeat, poultry complying with article 2.6 of Council Regulation 1906/90/EEC. 38 Glazed product A frozen product covered by a film of water which has been frozen. 39 Gross weight The total weight of a prepackage, including its container or wrapping. Drained weight Actual capacity 76/211/EEC 40 Group A number of packages of the same type and production run, forming the subject of a Batch reference test. 41 Import When someone brings goods from a third country to his own country inside the EEA. Third country A body who brings a package marked with the EEC mark into a Member State is not considered to import the package if he shows that the package is from a Member State in which it was liable to be tested in accordance with directives 76/211/EEC or 75/106/EEC and has not, since leaving that State been in a country which is not a Member State. 42 Importer Any person who places on the EEA market a product from a third country. 75/106/EEC, Article 5 43 Inadequate package A package which contains a quantity of goods which is less by more than twice a prescribed amount (TNE) than the nominal quantity on the package, i.e. with a net quantity below TU2. 44 Ingredient Any material, including additives, used during the production or preparation of a foodstuff and which are still present in the finished product, even if in altered form. 45 Inner package Packages placed in an outer package otherwise than in the presence of the purchaser, and which cannot be removed without opening the outer container. 46 Inscription The marks carried by a prepackage indicating the nominal quantity, the means to identify the packer or importer, and the e -mark. 47 Means to identify the packer A mark or inscription enabling the competent departments to identify the packer or the person arranging for the packing to be done or the importer established in the Community. Non-acceptable package 48 Inspection lot A part smaller than, or equal to, the batch. The sample is taken out of the lot. Batch ISO 3534 4.5 76/211/EEC, Article 6.4.a Marking 75/106 and 76/211/EEC, Annex I, 3 75/106 and 76/211/EEC, Annex I, 3.2 5
49 Label Any written, printed, or graphic matter affixed to, applied to, attached to, blown into, OIML R79 (1996), 2.3 formed or moulded into, embossed on, or appearing upon a package containing any product for purposes of branding, identifying, or giving any information with respect to the product or to the contents of the package; however, an inspector s tag or other non-promotional text affixed to or appearing upon a product shall not be deemed to be a label that requires the label information prescribed. 50 Labelling Any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a foodstuff and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such foodstuff. 79/112/EEC, Article 1.3.a 51 Legal measuring instrument Instrument specified in law, treated in accordance with the country s legal provisions regarding accuracy and traceability. 52 Liquid medium The following, possibly in mixtures and also when frozen or quick frozen, provided that the liquid is merely an adjunct to the essential elements of that preparation and is thus not a decisive factor for the purchase: water, aqueous solutions of salts, brine, aqueous solutions of food acids, vinegar, aqueous solutions of sugars, aqueous solutions of other sweetening substances, fruit or vegetable juices in the case of fruit or vegetables. 53 Marking The marks carried by a prepackage indicating the nominal quantity, the means to identify the packer or importer, and the e -mark. 54 Mean value requirement The requirement that the actual contents of the prepackages in a batch shall not be less, on average, than the nominal quantity. 55 Measuring container Volumetric legal measuring instrument that is not a measuring container bottle. 56 Measuring container bottle Containers commonly called bottles, made of glass or any other substance having such rigidity and stability that it offers the same metrological guarantees as glass, when such containers: 1. are stoppered or designed to be stoppered and are intended for storage, transport or delivery of liquids, 2. have a nominal capacity of between 0,05 litre and five litres inclusive, 3. have metrological characteristics (design characteristics and uniformity of manufacture) such that they can be used as measuring containers, i.e. when they are filled up to a specified level or to a specified percentage of their brim capacity their contents can be measured with sufficient accuracy. Prescribed equipment 75/106 and 76/211/EEC, Annex I, 4 79/112/EEC, Article 8.4 Inscription 75/106 and 76/211/EEC, Annex I, 3 75/106 and 76/211/EEC, Annex I, 1.1 75/107/EEC, Article 1 6
57 Metrological control Control exercised by the responsible authorities and relating to the methods and means of measurement used and the conditions under which the results of measurements are obtained, expressed and used. (Within the context of the Directive the responsible authorities are the competent departments.) 58 Minimum acceptable contents Contents calculated by subtracting the tolerable negative error for the contents concerned from the nominal quantity of the prepackage. 59 Minimum durability The date until which a foodstuff holds its specific properties, provided it is kept in good conditions. 60 Mixed packages Packages containing two or more individual packages or units of dissimilar commodities. 61 Multi-component package A special case of an outer package containing products of different kinds have to be mixed by the end-user in order to obtain an end-product ready for use. OIML Vocabulary of Legal Metrology (1978), 2.0 75/106 and 76/211/EEC, Article 3.2 75/106 and 76/211/EEC, Annex II, 2.2 TU1 OIML R79 (1996), note to 5.2 62 Negative error The quantity by which the actual contents of the prepackage are less than the nominal quantity. The quantity by which the actual volume of the contents is less than the nominal 76/211/EEC, Annex I, 2.3 75/106/EEC, Annex I, 2.3 volume of the contents of the prepackage. 63 Net capacity The volume in millilitres of a filled and closed aerosol dispenser. 75/324/EEC 64 Net contents The quantity of the commodity in the package exclusive of wrappers and any other material packed with such commodity. Where food has been glazed, the declaration of net contents of the food shall be exclusive of the glaze. 65 Net quantity The quantity of the identified product in the package exclusive of wrappers and any other material packed with such product. Note: This term relates to specifications in a package and does not account for the actual contents in an individual package. 66 Net weight The weight of the contents of a prepackage without its container or wrapping. 67 Nominal quantity The weight or volume indicated on the prepackage, i.e. the quantity of product which the prepackage is deemed to contain. OIML R87 Net quantity Codex Alimentarius ALINORM 95/18, Appendices II, III, IV, V, VI and VIII, 6.2 OIML R79 (1996), 2.2 Net contents 76/211/EEC, Annex I, 2.1 7
68 Nominal volume The volume indicated on the prepackage, i.e. the volume of liquid which the prepackage is deemed to contain. The volume which is marked on a measuring container bottle; it is the volume of liquid which the latter is deemed to contain when it is filled in the conditions of use for which it is intended. 75/106/EEC, Annex I, 2.1 75/107/EEC, Annex I, 1.1 69 Non-acceptable package A package which contains a quantity less than the nominal quantity minus twice the tolerable negative error. Inadequate package 70 Non-consumer package Any package intended solely for industrial or institutional use or for wholesale OIML R79 (1996), 2.7 distribution. 71 Non-destructive testing Testing which does not involve opening the package. 75/106 and 76/211/EEC, Annex II, 2 72 Non-returnable containers Containers which are used only once in the trade cycle producer-retailer-consumer. 73 Non-standard package A package containing a quantity of goods which is less by more than the prescribed amount (TNE) than the nominal quantity of the container, i.e. the net contents is below TU1. 74 Outer container A container containing inner packages or other containers. 75 Output of the packing line Defective prepackage The (hourly) production capacity of the packing line. 75/106 and 76/211/EEC, Annex II, 2.1.2 76 Package A container containing goods where the goods are placed for sale in the container otherwise than in the presence of the person purchasing the goods and none of the goods can be removed from the container without opening it. (In some countries this applies only to goods which are prescribed by Regulation.) The term package includes any container or wrapping in which any consumer commodity is enclosed for delivery or display of that commodity to consumers. 77 Packer The term packer is applied in the directives with a broad definition, as the person in a Member State responsible for the packing. 78 Packing line Those stages in the process of making up packages which occur between the time at which the goods to be made up are divided for that purpose and the time at which the packages are set aside for the purposes only of storage or distribution. 79 Person Person(s), both plural and singular, as the case demands, include individuals, partnerships, corporations, companies, societies, and associations. Prepackage 75/106/EEC, Annex,4 75/106/EEC Annex II, 2.1.2 OIML R79 (1996), 2.5 8
80 Placing on the market The moment when the product first passes from the stage of manufacture within the 75/106/EEC, Article 5 EEA to the stage of distribution and/or use on the EEA market. Since placing on the market refers only to the first time that the product is made available on the EEA market for distribution or use in the EEA, the directives apply only to new (or reconditioned) products manufactured in the EEA and to new (or reconditioned) or used products imported from a third country. 81 Prepackage The combination of a product and the individual package in which it is prepacked. 75/106 and 76/211/EEC, Article 2.1 82 Prepacked A product is prepacked when it is placed in a package of whatever nature without the purchaser being present and the quantity of product contained in the package has a predetermined value and cannot be altered without the package either being opened or undergoing a perceptible modification. 83 Prepacked foodstuff Any single item for presentation as such to the ultimate consumer, consisting of a foodstuff and the packing into which it was put before being offered for sale, whether such packaging encloses the foodstuff completely or only partially, but in any case in such a way that the contents cannot be altered without opening or changing the packaging. 84 Prepacked product Any commodity that is enclosed in a container or wrapped in any manner, and for which its quantity has been determined and indicated on its label prior to being offered for sale. 85 Prepacked products in predetermined quantities 86 Prepacked products in variable quantities Products prepacked in such a way that the quantity in the packing corresponds to a previously chosen value. A group of packages containing the same goods made up in circumstances where before the goods are placed in the packages, the packer has selected a particular quantity (being the same quantity for all packages in the group) as the quantity of the goods which he intends the packages to be treated as containing. Products prepacked in such a way that the quantity in the packing does not correspond to a previously chosen value. 9 Package 75/106 and 76/211/EEC, Article 2.2 79/112/EEC, Article 1.b OIML R79 (1996), 2.1 Constant quantity Catchweight products 87 Prescribed equipment Equipment that must comply with legal requirements. Legal measuring instrument 88 Prescribed quantity (standard size) (particular quantity) A quantity expressed by net weight or capacity by which specified goods shall be prepacked. 89 Principal display panel That part of a label that is most likely to be displayed, presented, shown, or examined under normal and customary conditions of display. OIML R79 (1996), 2.4 79/112/EEC, Article 11.3
90 Production checks Checks performed by the packer. 75/106 and 76/211/EEC, Annex I, 4 91 Production period The time it takes to produce a number of prepackages. 92 Production run The process whereby packages are made up in the same place during a period, or periods, in which the conditions under which (including the rate at which) the packages are made up do not materially alter. 93 Products sold by number 94 Products sold loose from bulk Products not sold by weight or volume (or length), and which cannot be fractionated without modifying their nature or their properties. Products which are only measured or weighed in presence of the buyer or by himself. 95 Quantity A measurable amount of something. 75/106 and 76/211/EEC, Annex II, 2.1.1 96 Quick frozen With regard to poultrymeat, poultry complying with Article 2.7 of Council Regulation 1906/90/EEC. 97 Recognised procedure Procedure presented to and recognised by a competent department. 75/106 and 76/211/EEC, Annex I, 4 98 Recorded results The records of checks of samples carried out by the packer or importer. 75/106 and 76/211/EEC, Annex I, 4 (clause 4) 99 Recording duty Obligation to perform and keep records. 75/106 and 76/211/EEC, Annex I, 4 (clause 5) 100 Reference method The method for statistical checking of batches of prepackages described in the Directives. 101 Reference temperature Temperature at which the contents of a prepackage has to meet the requirements of the Directives. 102 Reference test In relation to a group of prepackages, a test carried out on the group, for the purpose of ensuring that the prepackages comply with the requirements of Directives, according to the procedures laid down by the Directives. 103 Registration The person intending to e-mark shall register with a competent department of the Member State where the product is to be prepacked. (In some countries registration is not mandatory.) 104 Returnable containers The empty packing which can either be used and filled again or recycled. Reference test 75/106/EEC and 76/211/EEC, annex II 75/106/EEC and 76/211/EEC Reference method 75/106/EEC and 76/211/EEC 75/106/EEC and 76/211/EEC, Annex II 105 Sample A number of prepackages drawn at random from the batch. 75/106 and 76/211/EEC, Annex II, 2.1.4 ISO 3534 3.2 106 Sampling test Checking the net contents of the prepackages by means of samples. ISO 3534 4.4 107 Shrinkage Loss of weight or volume by evaporation. Desiccating goods 10
108 Single portion packs Products of maximum 20 g or 20 ml whose quantity has been determined for one and only use, or products of more than 20 g or 20 ml whose quantity has been determined for one and only use, indicated by the Minister competent for Economic Affairs who determines, if necessary, the quantity which may not be exceeded. 109 Small packages The term small packages includes such items as individual packets of salt, pepper, sugar, individually wrapped pieces of candy etc. 110 System for e-marking A name for the system set up by the Member State to register the packers/importers and their products and to perform periodical checks. 111 Tare weight The weight of a material of whatever nature which encloses the product. 112 Target weight The weight aimed at in the filling process (nominal weight plus overfill). 113 Templet A gauge for ascertaining the actual liquid level in a measuring container bottle or other relevant measuring container. 114 Third country A country not in the EEA. 115 Tolerable negative error TNE The tolerable negative error in the contents of a prepackage is fixed in accordance with the table below: [table shown in Annex I, 2.4 in the references]. When using the table, the values of the tolerable negative errors shown as percentages in the table shall be rounded up to the nearest one tenth of a gram or millilitre. Small packages OIML R79 (1996), note to 5.2 Single portion packs 75/106 and 76/211/EEC, Annex I, 2.4 116 TU1 The nominal quantity minus the tolerable negative error. Minimum acceptable contents 117 TU2 The nominal quantity minus twice the tolerable negative error. 118 Ultimate consumer The final consumer. This may include restaurants, hospitals, canteens, and similar institutions. 119 Uncertainty of measurement Parameter, associated with the result of a measurement, that characterises the dispersion of the values that could reasonably be attributed to the measurand. 120 Unit of measurement A unit which conforms to the definitions of Directive 80/181/EEC. 121 Weight In trade, a synonym for mass. 122 Wrapping A package of whatever nature which encloses the product. Consumer 79/112/EEC, Article 12 International Vocabulary of Basic and General Terms in Metrology (1993), 3.9 11